MAUDE Adverse Event Report: ENDOLOGIX INC. AFX; SUPRARENAL AORTIC EXTENSION

Model Number A25-25/C75-O20

Device Problems Failure To Adhere Or Bond (1031); Leak/Splash (1354); Stretched (1601); Unintended Movement (3026)

Patient Problems Aneurysm (1708); High Blood Pressure/ Hypertension (1908); Failure of Implant (1924); Pain (1994); Rupture (2208)

Event Date 10/20/2017

Event Type  Injury  

Manufacturer Narrative

The devices involved in the event will not be returned for evaluation, they remain implanted in the patient.If additional information pertinent to the incident is obtained, a follow-up report will be submitted.

Event Description

The patient was initially implanted with a bifurcated stent and a suprarenal aortic extension.On (b)(6) 2017 the patient came in emergently with a ruptured aorta.The patient was diagnosed with aneurysm sac growth and a hyper-dilation of the proximal suprarenal aortic extension.The physician implanted an additional bifurcated stent and two suprarenal aortic extensions to resolve the rupture.The final patient status was not initially reported to endologix.There have been no additional adverse events reported for this patient.

Manufacturer Narrative

At the completion of the clinical evaluation and based on the information received, there was substantial evidence to support the following reported events: ruptured aorta, dilation of sr stent by 24%, and reline procedure-bilateral renal artery snorkels.There was unsubstantial evidence to support the following reported events: aneurysm enlargement and sr cuff movement (unable to determine length due to lack of comparison imaging).The following reported events have been refuted: hypotensive, rather the patient was hypertensive and controlled medically.The following additional events were noted: (b)(6) 2017 (at 60 months post implant); type 1a endoleak and dissection lra-stent placed.The most likely cause of the loss of seal was related to the distal movement of the suprarenal extension.A tiny blush endoleak was noted in the medical records, seen six months prior to this event.Unable to definitively determine additional contributing factors due to a lack of medical records/imaging prior to the time of the event.Associated clinical harms for this event included: type ia endoleak, aneurysm enlargement, rupture, pain, and a secondary endovascular procedure.Procedure related harms included: dissection of the left renal artery.The most likely cause of the dilation of the suprarenal cuff by 24% was related to the strata graft material.There were no associated clinical harms with the stent dilation.The final patient disposition was not ascertained.There have been no additional adverse events reported for this patient.The manufacturing lot review confirmed all devices met specifications prior to release.This complaint is not capa eligible at this time.These types of events will be monitored and trended as part of the quality system.(b)(4).

• Brand Name: AFX
• Type of Device: SUPRARENAL AORTIC EXTENSION
• Manufacturer (Section D): ENDOLOGIX INC.; 2 musick; irvine CA 92618
• MDR Report Key: 7040753
• MDR Text Key: 92313108
• Report Number: 2031527-2017-00618
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• PMA/PMN Number: P040002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 05/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2015
• Device Model Number: A25-25/C75-O20
• Device Lot Number: W11-3040R-028
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/20/2017
• Initial Date FDA Received: 11/17/2017
• Supplement Dates Manufacturer Received: 10/20/2017
• Supplement Dates FDA Received: 05/16/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BIFURCATED STENT GRAFT- W11-5680-009; BIFURCATED STENT GRAFT- (B)(4).
• Patient Outcome(s): Required Intervention
• Patient Age: 83 YR